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Phase I Trial of DAR-901

This study has been completed.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: February 13, 2014
Last updated: August 1, 2016
Last verified: August 2016
This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.

Condition Intervention Phase
Tuberculosis Biological: DAR-901 Biological: BCG Biological: Sterile saline Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 10 months ]
    Subjects will be followed for both systemic side effects and injection site reactions

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 10 months ]
    Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine

Enrollment: 59
Study Start Date: February 2014
Study Completion Date: June 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAR-901

Intradermal administration at 0, 2 and 4 months

Three dose groups in dose escalation: 0.1 mg, 0.3 mg and 1.0 mg, all constituted in 0.1 mL

Biological: DAR-901
Active Comparator: BCG
Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos
Biological: BCG
Placebo Comparator: Sterile saline
Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos
Biological: Sterile saline


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All subjects: age 18-65, prior BCG vaccine (scar)

56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA)

21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA)

Exclusion Criteria: pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness

  Contacts and Locations
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Please refer to this study by its identifier: NCT02063555

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Principal Investigator: Charles F. von Reyn, MD Dartmouth College
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT02063555     History of Changes
Other Study ID Numbers: DAR-901-MDES
Study First Received: February 13, 2014
Last Updated: August 1, 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
TB Vaccines

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on September 25, 2017